Ocular Therapeutix Receives FDA Agreement Under Special Protocol Assessment for Registrational Trial of AXPAXLI

Ocular Therapeutix secures FDA SPA agreement for AXPAXLI registrational trial

The agreement is for a planned clinical trial of AXPAXLI (also known as OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).

Ocular Therapeutix receives FDA agreement under special protocol assessment for registrational trial of AXPAXLI

The agreement is for a planned clinical trial of AXPAXLI (also known as OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).

Ocular Therapeutix Secures FDA Special Protocol Assessment for NPDR Trial of Axpaxli

Ocular Therapeutix has received written agreement from the FDA under a Special Protocol Assessment (SPA) for the registrational trial design of Axpaxli (OTX-TKI) for the treatment of nonproliferative diabetic retinopathy (NPDR). Axpaxli (OTX-TKI) is an investigational, bioresorbable intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, under development for wet AM…